Pharmacovigilance knowledge repository

 One of my friend asked my advice for websites or resource for pharmacovigilance knowledge.

So i tried helping him, but i realized there is not enough one stop here we could find this, at least i have not found one. The list is exhaustive and will be updated, but something to start with.

1) Regulatory websites itself-
This websites are great source for enhancing knowledge or refreshing or simply keeping in touch with regulatory updates.If you subscribe to this website then authenticated first hand updates by regulatory bodies will be delivered to you in your mailbox.

FDA for US regulations, EMEA for European regulations, MHRA for UK regulations etc.

1) FDA website is vast storage of knowledge and once you browse it properly many courses and documents are available. If you subscribe there is also an option to subscribe for your domain only at here-http://www.fda.gov/ForHealthProfessionals/StayInformed/default.htm.

I found an important links to FDA where interesting courses are available.

FDA clinical investigator  program.

http://www.fda.gov/Training/ForHealthProfessionals/ucm091001.htm

FDA  course on new drug development-

http://www.accessdata.fda.gov/cder/sb-navigate/index.htm

FDA all stages of dug development program-

http://www.fda.gov/Training/ForHealthProfessionals/ucm209538.htm

FDA all 101 questions-

http://www.fda.gov/AboutFDA/WhatWeDo/ucm407684.htm

2) EMEA website-It is very informative and user friendly, navigation is quite easy and finding topics of your intrest  immeidately is easy too
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000258.jsp

3) MHRA-
UK has its own website dedicated as medicine and health regulatory activities.
Website is very informative, alphabetically SmPC(summary of product characteristics)/ package insert/CCDS  can be found easily on this website if required for any drugs at national level and also for European or other drugs external links are provided for package insert or labelling documents of that drugs.
All the updates are easily viewable on website.
https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety

4) For India-The Central Drugs Standard Control Organization (CDSCO) website is quite informative, but i feel the website needs more information and more updation on frequent basis.

http://www.cdsco.nic.in/forms/Default.aspx

Another website for India is pharmacovigilance program of India - http://www.ipc.gov.in/PvPI/pv_training.html

Other country specific website can be found as required on internet but this main guidelines or regulations form basis of most of the globally accepted PV principles.


5) UMC-To start with off course Uppsala monitoring center based in sweden which is headquarters for all PV activities. Although the website is not itself loaded with information it does guide on where to reach for each PV topic etc.

http://www.who-umc.org/DynPage.aspx?id=98079&mn1=7347&mn2=7252&mn3=7323

6) ICH website-
International conference on harmonization is basis of all guidelines for safety and regulatory, website is easy to navigate and subscription is again easy.
All required documents and guidelines like ICH E2A, E2B etc are freely available to download, and advantage is you will always refer to latest guidelines.

7) Training schedules are also available.
http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

8) Other sources are vast but it is important to know the difference between a good source of information and marketed websites.

Few that i found are good and also offer paid or free courses are detailed below.

1) Biopharma institute-This offers basic free PV courses and other information in domain.
http://www.biopharmainstitute.com/training-courses-books/Demo-elearning.php

2) DSRU- This institute provides paid training courses in Europe mostly, check out website the courses appear very well designed and informative.

http://www.biopharmainstitute.com/training-courses-books/Demo-elearning.php

3) EU2P website- This offers courses mainly on European regulations.
http://www.eu2p.org/diplomas-offer/certificates

4) ISOP website- Internatinal society of pharmacovigilance also offers courses and training materials.
http://isoponline.org/

5) Many pharma websites too host lot of updates on pharma domain news like pharmabiz, pharmatutor, http://www.pti-global.co.uk/, Fierce pharma-http://www.fiercepharma.com/,
IGMP institute India website-/http://www.igmpiindia.org/, applied clinical trials website-http://www.appliedclinicaltrialsonline.com/

6) Blogs- I really love blog Mr.Bart Cobert, a renowned and great PV expert, @http://www.telerx.com/author/bart-c/.

Another interesting and great blog is http://sjpharma.blogspot.com/2015/07/changing-dynamic-of-pharmacovigilance.html

Sarjen systems also have their webinars and very informative one's @ http://www.pvnet.in/.

Many CRO,KPO,BPO and pharma companies do host a space on their website where they ask their PV experts to write articles on PV topics, worth checking out.It is good to follow organisations like CRO,KPO, Pharma companies that keep on posting articles on PV on their social media account.

7) Social media-
I do not know much about Facebook, but Linkedin is very good tool to keep in touch with domain knowledge, their are many PV groups that you can join where articles on PV topics are posted like Budding regulatory professional, Pharmacovigilance experts, PV India, clinical trial group etc.



Thanks you for going through this exhaustive list, which is just a small effort, if you know any other good source do let me know too.

Till then keep reading,

Dr.shraddha Bhange.

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